Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study

• Status: Terminated
• Trial end date: 2019-01-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus

• Body weight of 20kg or less (actual, estimated, or measured)

• NPO for four hours or more

• Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.

Exclusion Criteria:

• Discretion of parents

• Discretion of provider

• Body weight greater than 20kg (actual, estimated, or measured)

• Starting Aldrete score <9/10

• Known or suspected psychosis

• Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure

• Significant elevation in blood pressure

• Known hypersensitivity to ketamine

• Non-English or Spanish speaking